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United States Files Complaint Against Forest Laboratories for Allegedly Violating the False Claims Act
Date:2/25/2009

Pharmaceutical Company Allegedly Marketed Drugs

for Unapproved Pediatric Use and Paid Kickbacks

WASHINGTON, Feb. 25 /PRNewswire-USNewswire/ -- A Complaint was unsealed today in U.S. District Court in Massachusetts against a New York pharmaceutical company for alleged False Claims Act violations arising from the company's marketing the drugs Celexa and Lexapro for unapproved pediatric use and for paying kickbacks to induce physicians to prescribe the drugs.

Acting Assistant Attorney General Michael F. Hertz; United States Attorney Michael J. Sullivan; Warren T. Bamford, Special Agent in Charge of the Federal Bureau of Investigation -- Boston Field Division; Susan J. Waddell, Special Agent in Charge of Health and Human Services -- Office of Inspector General, Office of Investigations; Mark Dragonetti, Resident Agent in Charge of the Food and Drug Administration, Office of Investigations -- Office of Inspector General; and Jeffrey Hughes, Special Agent in Charge of the Northeast Field Office of the Veterans Affairs Office of the Inspector General, announced that the civil Complaint against Forest Laboratories Inc., of New York, New York, alleged that the company's illegal promotional practices surrounding its antidepressant drugs Celexa and Lexapro caused thousands of false and fraudulent claims to be submitted to federal health care programs.

The Complaint alleges that a double-blind, placebo-controlled, pediatric trial found Celexa no more effective than the placebo for pediatric use and that, in the study, more patients taking Celexa attempted suicide or reported suicidal thoughts than those in the group taking the placebo. The negative efficacy data led the FDA to deny Forest's request to approve Celexa for pediatric use. It is further alleged that, despite the FDA's denial of a pediatric indication, Forest actively promoted pediatric use of the drugs and misled physicians and the public
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SOURCE U.S. Department of Justice
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